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Clinical Trial Results:
A 52-Week Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Summary
EudraCT number	2014-000478-20
Trial protocol	FI GB SE CZ NL PL
Global end of trial date	10 Jul 2017

Results information
Results version number	v2(current)
This version publication date	22 Jul 2018
First version publication date	09 Jul 2017
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B1481045

ISRCTN number

US NCT number

NCT02100514

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

02 Mar 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

10 Jul 2017

Was the trial ended prematurely?

Main objective of the trial

To demonstrate a superior low-density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615) 150 milligram (mg) administered by the subcutaneous (SC) route every 2 weeks (Q2W) compared to placebo, in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for cardiovascular events receiving statin therapy and whose LDL-C is greater or equal to (>=) 100 milligram per deciliter (mg/dL) (2.59 millimole per liter [mmol/L]).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Oct 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 79

Country: Number of subjects enrolled

Czech Republic: 35

Country: Number of subjects enrolled

Finland: 3

Country: Number of subjects enrolled

Korea, Republic of: 6

Country: Number of subjects enrolled

Netherlands: 38

Country: Number of subjects enrolled

Norway: 17

Country: Number of subjects enrolled

Poland: 71

Country: Number of subjects enrolled

Puerto Rico: 7

Country: Number of subjects enrolled

Singapore: 6

Country: Number of subjects enrolled

Sweden: 14

Country: Number of subjects enrolled

United Kingdom: 24

Country: Number of subjects enrolled

United States: 446

Worldwide total number of subjects

746

EEA total number of subjects

202

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

429

From 65 to 84 years

315

85 years and over

Subject disposition

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Recruitment details

Screening details

This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the Treatment Period and up to 10 July 2017 for the Extension Period.

Period 1 title

Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Carer, Subject

Are arms mutually exclusive

Yes

Treatment Period: Placebo

Arm description

Subjects received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks over a period of 52 weeks.

Treatment Period: Bococizumab (PF-04950615) 150 mg

Arm description

Subjects received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Arm type

Experimental

Investigational medicinal product name

Bococizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks over a period of 52 weeks.

Number of subjects in period 1	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Started	247	499
Completed	218	425
Not completed	29	74
Consent withdrawn by subject	12	37
Did Not Meet Entrance Criteria	-	1
Death	2	2
Adverse event	-	5
Unspecified	9	11
Lost to follow-up	5	17
Protocol deviation	1	1

Period 2 title

Extension Period

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Extension Period: Placebo

Arm description

Subjects randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for serious adverse events (SAEs) and concomitant medications up to Week 110.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Extension Period: Bococizumab ADA positive

Arm description

Subjects randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, subjects who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 [log2] units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Extension Period: Bococizumab ADA negative

Arm description

Subjects randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Subjects who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2 ^[1]	Extension Period: Placebo	Extension Period: Bococizumab ADA positive	Extension Period: Bococizumab ADA negative
Started	44	33	56
Completed	42	33	56
Not completed	2	0	0
Consent withdrawn by subject	2	-	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Only subjects who consented for the extension period were followed in the extension period.

Baseline characteristics

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Reporting group title

Treatment Period: Placebo

Reporting group description

Subjects received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Reporting group title

Treatment Period: Bococizumab (PF-04950615) 150 mg

Reporting group description

Subjects received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Reporting group values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg	Total
Number of subjects	247	499	746
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	144	285	429
From 65-84 years	102	213	315
85 years and over	1	1	2
Age Continuous
Units: years
arithmetic mean (standard deviation)	61.7 ( 10.0 )	61.5 ( 9.9 )	-
Gender, Male/Female
Units: Subjects
Female	107	223	330
Male	140	276	416

End points

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Reporting group title

Treatment Period: Placebo

Reporting group description

Subjects received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Reporting group title

Treatment Period: Bococizumab (PF-04950615) 150 mg

Reporting group description

Subjects received Bococizumab (PF-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Reporting group title

Extension Period: Placebo

Reporting group description

Reporting group title

Extension Period: Bococizumab ADA positive

Reporting group description

Reporting group title

Extension Period: Bococizumab ADA negative

Reporting group description

Primary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

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End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

End point description

Full analysis set (FAS) included all subjects who were randomized. Here, "Number of subjects analyzed (N)" signifies number of subjects who were evaluable for this endpoint.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	235	468
Units: percent change
arithmetic mean (standard deviation)	-0.8 ( 17.61 )	-50.8 ( 29.81 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

703

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-49.9

Confidence interval

level

95%

sides

2-sided

lower limit

-54

upper limit

-45.8

Variability estimate

Standard error of the mean

Dispersion value

2.09

Secondary: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 469)	-2.2 ( 13.41 )	-35.4 ( 20.93 )
Week 24 (n =237, 463)	-3.1 ( 15.79 )	-32.9 ( 23.06 )
Week 52 (n =221, 425)	-5.0 ( 17.22 )	-29.0 ( 22.08 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-33.2

Confidence interval

level

95%

sides

2-sided

lower limit

-36.1

upper limit

-30.2

Variability estimate

Standard error of the mean

Dispersion value

1.48

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-29.6

Confidence interval

level

95%

sides

2-sided

lower limit

-32.8

upper limit

-26.3

Variability estimate

Standard error of the mean

Dispersion value

1.66

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-23.8

Confidence interval

level

95%

sides

2-sided

lower limit

-27

upper limit

-20.5

Variability estimate

Standard error of the mean

Dispersion value

1.65

Secondary: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =234, 467)	-0.6 ( 16.70 )	-46.5 ( 28.87 )
Week 24 (n =236, 461)	-2.1 ( 18.66 )	-43.5 ( 32.26 )
Week 52 (n =221, 425)	-4.4 ( 20.77 )	-37.3 ( 29.59 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-45.6

Confidence interval

level

95%

sides

2-sided

lower limit

-49.6

upper limit

-41.6

Variability estimate

Standard error of the mean

Dispersion value

2.04

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-40.9

Confidence interval

level

95%

sides

2-sided

lower limit

-45.3

upper limit

-36.5

Variability estimate

Standard error of the mean

Dispersion value

2.26

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-32.5

Confidence interval

level

95%

sides

2-sided

lower limit

-36.7

upper limit

-28.2

Variability estimate

Standard error of the mean

Dispersion value

2.17

Secondary: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 469)	-2.6 ( 17.57 )	-47.6 ( 28.36 )
Week 24(n =237, 463)	-3.8 ( 20.63 )	-44.7 ( 30.83 )
Week 52 (n =221, 425)	-6.4 ( 22.70 )	-39.5 ( 29.36 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-44.9

Confidence interval

level

95%

sides

2-sided

lower limit

-48.8

upper limit

-41

Variability estimate

Standard error of the mean

Dispersion value

1.99

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-40.5

Confidence interval

level

95%

sides

2-sided

lower limit

-44.8

upper limit

-36.1

Variability estimate

Standard error of the mean

Dispersion value

2.21

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-32.7

Confidence interval

level

95%

sides

2-sided

lower limit

-37

upper limit

-28.4

Variability estimate

Standard error of the mean

Dispersion value

2.2

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

End point description

A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	164	331
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =158, 313)	0.5 ( 16.61 )	-51.1 ( 30.43 )
Week 24 (n =159, 311)	-1.6 ( 21.68 )	-48.4 ( 33.67 )
Week 52 (n =148, 292)	-4.2 ( 24.11 )	-42.2 ( 33.75 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-51.6

Confidence interval

level

95%

sides

2-sided

lower limit

-56.7

upper limit

-46.6

Variability estimate

Standard error of the mean

Dispersion value

2.59

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-46.4

Confidence interval

level

95%

sides

2-sided

lower limit

-52.2

upper limit

-40.6

Variability estimate

Standard error of the mean

Dispersion value

2.94

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-37.4

Confidence interval

level

95%

sides

2-sided

lower limit

-43.3

upper limit

-31.4

Variability estimate

Standard error of the mean

Dispersion value

3.03

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

End point description

A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	83	168
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =77,155)	-3.4 ( 19.34 )	-50.1 ( 28.62 )
Week 24 (n =77,150)	-5.7 ( 21.67 )	-45.8 ( 33.13 )
Week 52 (n =74,133)	-5.7 ( 23.78 )	-40.9 ( 30.25 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-46.6

Confidence interval

level

95%

sides

2-sided

lower limit

-53.7

upper limit

-39.5

Variability estimate

Standard error of the mean

Dispersion value

3.59

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-39.7

Confidence interval

level

95%

sides

2-sided

lower limit

-47.9

upper limit

-31.6

Variability estimate

Standard error of the mean

Dispersion value

4.12

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-33.4

Confidence interval

level

95%

sides

2-sided

lower limit

-41.3

upper limit

-25.5

Variability estimate

Standard error of the mean

Dispersion value

4.02

Secondary: Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52

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End point title

Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =235, 469)	4.9 ( 54.24 )	-25.7 ( 29.45 )
Week 24 (n =235, 463)	5.9 ( 50.52 )	-21.3 ( 34.42 )
Week 52 (n =221, 425)	27.9 ( 374.64 )	-21.5 ( 32.61 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

-30.8

Confidence interval

level

95%

sides

2-sided

lower limit

-36.9

upper limit

-24.6

Variability estimate

Standard error of the mean

Dispersion value

3.14

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-27.5

Confidence interval

level

95%

sides

2-sided

lower limit

-33.9

upper limit

-21.2

Variability estimate

Standard error of the mean

Dispersion value

3.23

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-49.4

Confidence interval

level

95%

sides

2-sided

lower limit

-85.2

upper limit

-13.5

Variability estimate

Standard error of the mean

Dispersion value

18.27

Secondary: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 469)	0.6 ( 13.93 )	6.3 ( 13.86 )
Week 24 (n =237, 463)	0.6 ( 14.88 )	6.3 ( 14.49 )
Week 52 (n =221, 425)	0.7 ( 14.24 )	7.0 ( 15.60 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

MMRM

Parameter type

LS mean difference compared to placebo

Point estimate

5.5

Confidence interval

level

95%

sides

2-sided

lower limit

3.4

upper limit

7.6

Variability estimate

Standard error of the mean

Dispersion value

1.06

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

5.4

Confidence interval

level

95%

sides

2-sided

lower limit

3.2

upper limit

7.6

Variability estimate

Standard error of the mean

Dispersion value

1.14

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

3.6

upper limit

8.3

Variability estimate

Standard error of the mean

Dispersion value

1.2

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52: Treatment Period

Top of page

End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52: Treatment Period

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 24 (n =236, 461)	-2.9 ( 21.72 )	-47.5 ( 33.48 )
Week 52 (n =222, 425)	-4.7 ( 23.96 )	-41.8 ( 32.67 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-44.2

Confidence interval

level

95%

sides

2-sided

lower limit

-48.8

upper limit

-39.5

Variability estimate

Standard error of the mean

Dispersion value

2.39

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-36.2

Confidence interval

level

95%

sides

2-sided

lower limit

-40.9

upper limit

-31.4

Variability estimate

Standard error of the mean

Dispersion value

2.42

Secondary: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 469)	-6.2 ( 32.92 )	-16.2 ( 32.86 )
Week 24 (n =237, 463)	-8.9 ( 35.60 )	-18.2 ( 65.13 )
Week 52 (n =221, 425)	-8.0 ( 41.46 )	-15.8 ( 35.57 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-10.1

Confidence interval

level

95%

sides

2-sided

lower limit

-15.1

upper limit

-5.1

Variability estimate

Standard error of the mean

Dispersion value

2.55

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-17.9

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

4.5

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-8.2

Confidence interval

level

95%

sides

2-sided

lower limit

-14.1

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

3.04

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 468)	-0.9 ( 11.09 )	3.4 ( 11.43 )
Week 24 (n =236, 461)	-1.6 ( 10.81 )	2.5 ( 11.61 )
Week 52 (n =221, 425)	-1.0 ( 13.12 )	3.4 ( 11.77 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

4.1

Confidence interval

level

95%

sides

2-sided

lower limit

2.5

upper limit

5.8

Variability estimate

Standard error of the mean

Dispersion value

0.85

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

3.8

Confidence interval

level

95%

sides

2-sided

lower limit

2.2

upper limit

5.5

Variability estimate

Standard error of the mean

Dispersion value

0.86

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

4.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

6.2

Variability estimate

Standard error of the mean

Dispersion value

0.97

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =235, 468)	2.0 ( 11.94 )	3.0 ( 11.94 )
Week 24 (n =233, 462)	2.6 ( 12.12 )	3.7 ( 14.12 )
Week 52 (n =220, 423)	0.7 ( 12.46 )	1.9 ( 12.22 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.9

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

0.95

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.04

Secondary: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

Top of page

End point title

Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percent change
arithmetic mean (standard deviation)
Week 12 (n =236, 469)	-6.2 ( 32.92 )	-16.2 ( 32.86 )
Week 24 (n =237, 463)	-8.9 ( 35.60 )	-18.2 ( 65.13 )
Week 52 (n =221, 425)	-8.0 ( 41.46 )	-15.8 ( 35.57 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-10.1

Confidence interval

level

95%

sides

2-sided

lower limit

-15.1

upper limit

-5.1

Variability estimate

Standard error of the mean

Dispersion value

2.55

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-17.9

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

4.5

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-8.2

Confidence interval

level

95%

sides

2-sided

lower limit

-14.1

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

3.04

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12

End point description

A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	164	331
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =164, 331)	130.1 ( 25.22 )	130.2 ( 28.72 )
Change at Week 12 (n =158, 313)	-0.5 ( 22.37 )	-67.3 ( 40.14 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-66.8

Confidence interval

level

95%

sides

2-sided

lower limit

-73

upper limit

-60.5

Variability estimate

Standard error of the mean

Dispersion value

3.18

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12

End point description

A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here,"n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	83	168
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =83, 168)	143.7 ( 35.49 )	147.2 ( 39.48 )
Change at Week 12 (n =77, 155)	-6.6 ( 29.61 )	-74.1 ( 48.04 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-66.1

Confidence interval

level

95%

sides

2-sided

lower limit

-76.7

upper limit

-55.4

Variability estimate

Standard error of the mean

Dispersion value

5.4

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	134.7 ( 29.71 )	135.9 ( 33.67 )
Change at Week 12 (n =235, 468)	-2.5 ( 25.07 )	-69.6 ( 42.98 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-66.5

Confidence interval

level

95%

sides

2-sided

lower limit

-72

upper limit

-61.1

Variability estimate

Standard error of the mean

Dispersion value

2.77

Secondary: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	209.4 ( 33.84 )	210.3 ( 37.97 )
Change at Week 12 (n =236, 469)	-5.9 ( 29.61 )	-75.4 ( 46.91 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-69.1

Confidence interval

level

95%

sides

2-sided

lower limit

-75.2

upper limit

-63.1

Variability estimate

Standard error of the mean

Dispersion value

3.08

Secondary: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	160.2 ( 33.49 )	162.1 ( 37.78 )
Change at Week 12 (n =236, 469)	-5.8 ( 29.59 )	-77.9 ( 48.28 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-71.3

Confidence interval

level

95%

sides

2-sided

lower limit

-77.5

upper limit

-65.1

Variability estimate

Standard error of the mean

Dispersion value

3.14

Secondary: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	106.1 ( 20.43 )	107.1 ( 23.33 )
Change at Week 12 (n =234, 467)	-1.6 ( 18.09 )	-49.8 ( 31.81 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-47.7

Confidence interval

level

95%

sides

2-sided

lower limit

-51.9

upper limit

-43.6

Variability estimate

Standard error of the mean

Dispersion value

2.12

Secondary: Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12

Top of page

End point title

Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	48.5 ( 54.04 )	47.3 ( 53.55 )
Change at Week 12 (n =235, 469)	0.1 ( 10.91 )	-10.3 ( 17.01 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-10.4

Confidence interval

level

95%

sides

2-sided

lower limit

-12.5

upper limit

-8.3

Variability estimate

Standard error of the mean

Dispersion value

1.06

Secondary: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

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End point title

Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n =247, 499)	49.2 ( 13.20 )	48.3 ( 11.60 )
Change at Week 12 (n =236, 469)	-0.1 ( 6.75 )	2.5 ( 6.64 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

2.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

3.6

Variability estimate

Standard error of the mean

Dispersion value

0.52

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

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End point title

Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: ratio
arithmetic mean (standard deviation)
Baseline (n =247, 499)	4.6 ( 1.90 )	4.6 ( 1.31 )
Change at Week 12 (n =236, 469)	-0.2 ( 1.27 )	-1.8 ( 1.29 )
Change at Week 24 (n =237, 463)	-0.2 ( 1.42 )	-1.6 ( 1.38 )
Change at Week 52 (n =221, 425)	-0.2 ( 1.62 )	-1.5 ( 1.32 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-1.6

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

-1.5

Variability estimate

Standard error of the mean

Dispersion value

0.08

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

-1.3

Variability estimate

Standard error of the mean

Dispersion value

0.1

Placebo vs PF-04950615 150 mg

Statistical analysis description

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

-1.2

Variability estimate

Standard error of the mean

Dispersion value

0.12

Secondary: Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

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End point title

Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: ratio
arithmetic mean (standard deviation)
Baseline (n =247, 499)	0.7 ( 0.25 )	0.8 ( 0.22 )
Change at Week 12 (n =234, 467)	0.0 ( 0.14 )	-0.4 ( 0.25 )
Change at Week 24 (n =236, 461)	-0.0 ( 0.16 )	-0.3 ( 0.27 )
Change at Week 52 (n =221, 425)	0.0 ( 0.66 )	-0.3 ( 0.25 )

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.02

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.02

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

LS mean difference compared to placebo

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.04

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

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End point title

Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percentage of subjects
number (not applicable)
Week 12 (n =235, 468)	10.2	81.6
Week 24 (n =236, 461)	19.9	75.1
Week 52 (n =222, 425)	25.2	72.7

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

53.9

Confidence interval

level

95%

sides

2-sided

lower limit

32.08

upper limit

90.59

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

11.15

upper limit

26.07

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

9.1

Confidence interval

level

95%

sides

2-sided

lower limit

6.18

upper limit

13.48

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

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End point title

Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

End point description

FAS included all subjects who were randomized. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Week 12, 24, 52

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percentage of subjects
number (not applicable)
Week 12 (n =235, 468)	1.3	62.2
Week 24 (n =236, 461)	1.7	60.1
Week 52 (n 222, 425)	3.2	53.4

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

156.4

Confidence interval

level

95%

sides

2-sided

lower limit

48.84

upper limit

501.11

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

110.8

Confidence interval

level

95%

sides

2-sided

lower limit

39.77

upper limit

308.46

Placebo vs PF-04950615 150 mg

Statistical analysis description

Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.

Comparison groups

Treatment Period: Placebo v Treatment Period: Bococizumab (PF-04950615) 150 mg

Number of subjects included in analysis

746

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Odds ratio (OR)

Point estimate

43.3

Confidence interval

level

95%

sides

2-sided

lower limit

19.52

upper limit

96.13

Secondary: Plasma Concentration Versus Time Summary of PF-04950615

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End point title

Plasma Concentration Versus Time Summary of PF-04950615 ^[1]

End point description

Analysis set included all subjects who had taken at least 1 dose of Bococizumab (PF-04950615) 150 mg. Here, "n" signifies number of subjects who were evaluable at the specified time points.

End point type

Secondary

End point timeframe

Week 12, 24, 52

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to be analyzed for Bococizumab 150 mg arm (treatment period) only.

End point values	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	499
Units: microgram per milliliter
geometric mean (standard deviation)
Week 12 (n =456)	5.37 ( 5.327 )
Week 24 (n =448)	5.28 ( 5.888 )
Week 52 (n =418)	4.01 ( 4.652 )

No statistical analyses for this end point

Secondary: Percentage of Subjects With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions

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End point title

Percentage of Subjects With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions

End point description

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Subjects with type 1 or type 3 hypersensitivity reactions and subjects with injection site reactions were reported in this endpoint.

End point type

Secondary

End point timeframe

Baseline up to end of study (up to 110 weeks)

End point values	Treatment Period: Placebo	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	247	499
Units: percentage of subjects
number (not applicable)
With type 1 or 3 hypersensitivity reactions	0.0	0.2
With injection site reactions	0.8	13.4

No statistical analyses for this end point

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period

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End point title

Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period ^[2]

End point description

Percentage of subjects with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive. Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This endpoint was planned not to be analysed for placebo reporting arm. Here, "N" signifies number of subjects who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline up to Week 58

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to be analyzed for Bococizumab 150 mg arm (treatment period) only.

End point values	Treatment Period: Bococizumab (PF-04950615) 150 mg
Number of subjects analysed	491
Units: Percentage of subjects
number (not applicable)
Baseline up to Week 58: ADA positive	54.8
Baseline up to Week 58: nAb positive	37.9

No statistical analyses for this end point

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

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End point title

Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

End point description

Percentage of subjects with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive. All subjects who consented for extension period. This endpoint was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, "n" signifies number of participants who were evaluable at specified time points.

End point type

Secondary

End point timeframe

Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110

End point values	Extension Period: Bococizumab ADA positive
Number of subjects analysed	33
Units: percentage of subjects
number (not applicable)
Week 58 (follow up): ADA positive (n =33)	100.0
Week 58 (follow up): nAB positive (n =33)	60.6
Week 71: ADA positive (n =31)	87.1
Week 71: nAb positive (n =31)	35.5
Week 84: ADA positive (n =28)	82.1
Week 84: nAb positive (n =28)	25.0
Week 97: ADA postive (n =22)	86.4
Week 97: nAb positive (n =22)	18.2
Week 110: ADA positive (n =17)	100.0
Week 110: nAb positive (n =17)	11.8

No statistical analyses for this end point

Secondary: Number of Subjects Who Changed Concomitant Medication During Extension Period

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End point title

Number of Subjects Who Changed Concomitant Medication During Extension Period

End point description

In this endpoint, total number of subjects who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported. All subjects who consented for extension period.

End point type

Secondary

End point timeframe

Week 58 follow-up to Week 110

End point values	Extension Period: Placebo	Extension Period: Bococizumab ADA positive	Extension Period: Bococizumab ADA negative
Number of subjects analysed	44	33	56
Units: subjects	2	4	3

No statistical analyses for this end point

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (follow up), 71, 84, 97 and 110: Extension Period

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End point title

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (follow up), 71, 84, 97 and 110: Extension Period

End point description

All subject who consented for extension period. This endpoint was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period).

End point type

Secondary

End point timeframe

Baseline, Week 58 (follow up), 71, 84, 97, 110

End point values	Extension Period: Bococizumab ADA positive
Number of subjects analysed	33
Units: percent change
arithmetic mean (standard deviation)
Week 58 (follow up)	6.7 ( 27.70 )
Week 71	8.7 ( 34.83 )
Week 84	7.0 ( 30.34 )
Week 97	2.6 ( 31.43 )
Week 110	15.5 ( 36.17 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58

Adverse event reporting additional description

Event may be serious in 1 and nonserious in other subject or 1 subject may have experienced both serious and nonserious AE. Subjects evaluable:treatment period: subjects who received at least 1 dose of study drug;extension period:subjects who consented for extension period.Nonserious AEs were not collected for extension period.99999=not available.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Placebo

Reporting group description

Subjects received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Subjects were followed up to Week 58.

Reporting group title

Bococizumab (PF-04950615) 150 mg

Reporting group description

Subjects received Bococizumab (PF04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Sujects were followed up to Week 58.

Reporting group title

Extension Period: Placebo

Reporting group description

Subjects randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.‌

Reporting group title

Extension Period: Bococizumab ADA positive

Reporting group description

Subjects randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, subjects who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 log2 units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.

Reporting group title

Extension Period: Bococizumab ADA negative

Reporting group description

Serious adverse events	Placebo	Bococizumab (PF-04950615) 150 mg	Extension Period: Placebo	Extension Period: Bococizumab ADA positive	Extension Period: Bococizumab ADA negative
Total subjects affected by serious adverse events
subjects affected / exposed	32 / 247 (12.96%)	44 / 499 (8.82%)	2 / 44 (4.55%)	0 / 33 (0.00%)	1 / 56 (1.79%)
number of deaths (all causes)	2	2	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer recurrent
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	1 / 247 (0.40%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disease progression
alternative dictionary used: MedDRA v20.0J
subjects affected / exposed	0 / 247 (0.00%)	0 / 499 (0.00%)	1 / 44 (2.27%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral artery dissection
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
POSSIBLE SEIZURE DISORDER SECONDARY TO AMPHETAMINE ABUSE
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthenia
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest pain
subjects affected / exposed	1 / 247 (0.40%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	1 / 247 (0.40%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 247 (0.00%)	5 / 499 (1.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular stent occlusion
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 247 (0.00%)	2 / 499 (0.40%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest pain
alternative dictionary used: MedDRA v20.0J
subjects affected / exposed	0 / 247 (0.00%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
alternative dictionary used: MedDRA v 20.0J
subjects affected / exposed	0 / 247 (0.00%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	1 / 56 (1.79%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Depression suicidal
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Paranoia
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric decompensation
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal behaviour
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Arterial injury
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	2 / 247 (0.81%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 247 (0.40%)	3 / 499 (0.60%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	2 / 247 (0.81%)	4 / 499 (0.80%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 247 (0.00%)	2 / 499 (0.40%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	2 / 247 (0.81%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	3 / 247 (1.21%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation1
alternative dictionary used: MedDRA 20.0J
subjects affected / exposed	0 / 247 (0.00%)	0 / 499 (0.00%)	1 / 44 (2.27%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
alternative dictionary used: MedDRA 20.0J
subjects affected / exposed	0 / 247 (0.00%)	0 / 499 (0.00%)	1 / 44 (2.27%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral haematoma
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	0 / 247 (0.00%)	3 / 499 (0.60%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Miller Fisher syndrome
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 247 (0.40%)	2 / 499 (0.40%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Sudden hearing loss
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	2 / 247 (0.81%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal perforation
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	1 / 247 (0.40%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bursitis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spondyloarthropathy
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Arthritis bacterial
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 247 (0.40%)	2 / 499 (0.40%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 247 (0.40%)	0 / 499 (0.00%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypoglycaemia
subjects affected / exposed	0 / 247 (0.00%)	1 / 499 (0.20%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	Bococizumab (PF-04950615) 150 mg	Extension Period: Placebo	Extension Period: Bococizumab ADA positive	Extension Period: Bococizumab ADA negative
Total subjects affected by non serious adverse events
subjects affected / exposed	29 / 247 (11.74%)	97 / 499 (19.44%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
General disorders and administration site conditions
Injection site reaction
Additional description: For extension Period, NSAEs were not collected and hence actual population exposed is "0". Current presentation is a resolution of database limitation.
alternative assessment type: Systematic
subjects affected / exposed	2 / 247 (0.81%)	67 / 499 (13.43%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences all number	2	328	0	0	0
Infections and infestations
Nasopharyngitis
Additional description: For extension Period, NSAEs were not collected and hence actual population exposed is "0". Current presentation is a resolution of database limitation.
alternative assessment type: Systematic
subjects affected / exposed	14 / 247 (5.67%)	17 / 499 (3.41%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences all number	19	18	0	0	0
Upper respiratory tract infection
Additional description: For extension Period, NSAEs were not collected and hence actual population exposed is "0". Current presentation is a resolution of database limitation.
alternative assessment type: Systematic
subjects affected / exposed	14 / 247 (5.67%)	18 / 499 (3.61%)	0 / 44 (0.00%)	0 / 33 (0.00%)	0 / 56 (0.00%)
occurrences all number	16	21	0	0	0

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Were there any global substantial amendments to the protocol? Yes

29 Jul 2014

Study follow-up period was reduced from 8 to 6 weeks.

17 May 2016

For US sites, addition of a substudy to provide additional follow up of subjects who were ADA positive at the last study visit.

07 Jul 2016

For US sites, addition of a substudy that provides additional follow-up of subjects who were ADA positive and information on use of concomitant medication, LDL-C,and to not discontinue subjects who start treatment with a PCSK9 inhibitor.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A 52-Week Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Primary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52: Treatment Period

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52: Treatment Period

Secondary: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

Secondary: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram per Deciliter (mg/dL) at Week 12

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram per Deciliter (mg/dL) at Week 12

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

Secondary: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

Secondary: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12

Secondary: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (non HDL-C) at Week 12

Secondary: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

Secondary: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

Secondary: Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12

Secondary: Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12

Secondary: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

Secondary: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

Secondary: Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (mg/dL) at Week 12, 24 and 52

Secondary: Plasma Concentration Versus Time Summary of PF-04950615

Secondary: Plasma Concentration Versus Time Summary of PF-04950615

Secondary: Percentage of Subjects With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions

Secondary: Percentage of Subjects With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

Secondary: Percentage of Subjects With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

Secondary: Number of Subjects Who Changed Concomitant Medication During Extension Period

Secondary: Number of Subjects Who Changed Concomitant Medication During Extension Period

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (follow up), 71, 84, 97 and 110: Extension Period

Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (follow up), 71, 84, 97 and 110: Extension Period

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A 52-Week Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events